Ignite Creation Date:
2024-05-06 @ 8:02 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02658669
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2016-01-11
Brief Title:
Cognitive-Behavioral Therapy for Veterans With TBI
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many Operation Enduring FreedomOperation Iraqi FreedomOperation New Dawn era Veterans have suffered a mild traumatic brain injury mTBI and now cope with multiple post-injury symptoms including sleep disturbances especially insomnia Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms delay recovery and negatively affect many of the cognitive psychological and neuromuscular sequelae of mTBI thereby decreasing quality of life Although Cognitive-Behavioral Therapy for Insomnia CBT-I has been shown to be an effective evidence-based treatment for insomnia there are no published randomized controlled trials evaluating the potential strengths andor limitations of CBT-I in post-mTBI patients Therefore assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI
Detailed Description:
This VA Rehabilitation Research and Development Career Development Award CDA-2 proposal is designed to significantly advance the application of Behavioral Sleep Medicine practices in the treatment of Veterans seen in the VA Healthcare System especially those recovering from traumatic brain injury TBI TBI has been deemed the signature wound of the Iraq and Afghanistan Wars occurring in about 195 of Operation Enduring FreedomOperation Iraqi FreedomOperation New Dawn OEFOIFOND service members For many Veterans mild traumatic brain injury mTBI can be associated with persistent post-concussive symptoms especially sleep disturbances Sleep disturbances are among the most frequent complaints following mTBI with studies suggesting that over 93 of Veterans who experienced brain injuries develop chronic sleep problems Of the sleep disturbances diagnosed in this patient population the most common is insomnia observed in over 50 of patients Chronic and untreated insomnia is known to be associated with andor increase risk for psychiatric problems suicidal ideation and unhealthy lifestyles eg alcoholdrug abuse lead to poorer physical health disruption in major social and occupational responsibilities and decreased quality of life and may generally contribute to the persistence of post-concussive symptoms beyond the expected period of recovery As such treatment of sleep disturbance represents an essential component of Veteran care one which may be particularly beneficial for Veterans with history of mTBI who commonly present to the clinic with complex multi-symptom concerns
To address this important clinical issue the proposed randomized clinical trial RCT will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia CBT-I versus a Sleep Education control in Veterans with insomnia and a history of mTBI CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program Despite the acceptance of CBT-I as a first line treatment for sleep disturbance there are no published RCTs evaluating CBT-I in mTBI patient populations Therefore this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury
To address this important clinical issue the proposed randomized clinical trial RCT will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia CBT-I versus a Sleep Education control in Veterans with insomnia and a history of mTBI CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program Despite the acceptance of CBT-I as a first line treatment for sleep disturbance there are no published RCTs evaluating CBT-I in mTBI patient populations Therefore this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None